Last month, the FDA announced an urgent recall of the Penumbra Jet 7 Xtra Flex Catheter, used to clear stroke-causing blood clots.
This catheter is used in thrombectomy procedures for ischemic stroke. Unfortunately, in December 2020, it was recalled after 18 reported deaths in addition to dozens of injuries. If you suffered an ischemic stroke that required surgery after May 2019, you may be affected. Patients and their families have reported second strokes, brain bleeds, vessel damage, cerebral infarction, and also death.
How Does the Penumbra Jet 7 Xtra Flex Catheter Work?
This catheter system is threatened through the artery until it reaches the stroke-causing clot. The aspiration system then uses suction force to clear the blockage. However, there are problems associated with this device. In some procedures, the distal tip has broken off the device, detaching inside the brain. Others have reported that when surgeons inject a contrast agent to help blood flow, the Xtra Flex may expand like a balloon and cause the blood vessel to rupture, leading to hemorrhaging and/or death.
Why Was the Xtra Flex Catheter Approved?
Penumbra used the FDA’s 501(k) Fast-Track clearance to quickly get this device approved. More than 30,000 units have been recalled. This clearance allows the FDA to approve devices that are similar to those already on the market.